Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, Congress passed a CR to fund the federal government through December 20, 2024, and CMS released guidance on coverage requirements for children enrolled in Medicaid and CHIP.
I. Regulations, Notices & Guidance
- On September 24, 2024, the Food and Drug Administration (FDA) released a notice entitled, Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices. FDA is releasing this proposed amendment to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative HBV antibody assays and quantitative assays that detect anti-HBs (antibodies to HBV surface antigen (HBsAg)), and quantitative HBV nucleic acid-based assays, all of which are post-amendments class III devices, into class II (general controls and special controls), subject to premarket notification. FDA is also proposing three new device classification regulations along with the special controls that the agency believes are necessary to provide a reasonable assurance of safety and effectiveness for each device.
- On September 24, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Delegation of Authority; Public Health Service Act. This notice announces the delegation of authority to the Head of Contracting Activity, Director Office of Acquisition Services, CDC. CDC has delegated the authority under section 305(e) of the Public Health Service (PHS) Act, as amended, to (1) enter into transactions other than a contract, grant, or cooperative agreement for purposes of infectious disease research, biosurveillance, infectious disease modeling, and public health preparedness and response for CDC. This includes the authority to award, modify, administer, and terminate other transactions. (2) With respect to a project that is expected to cost more than $40,000,000, any delegated or redelegated authority under item (1) above to the Head of the Contracting Activity may only be exercised upon a written determination by the Assistant Secretary for Financial Resources, that the use of such authority is essential to promoting the success of the project. The authority of the Assistant Secretary for Financial Resources under section 305(e)(2) of the PHS Act as amended, may not be delegated. This authority may be redelegated unless redelegation is otherwise prohibited by law, regulation, other delegation, or policy.
- On September 25, 2025, the Centers for Medicare & Medicaid Services (CMS) released a final rule entitled, Medicare Program: Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023. This final rule addresses policies for assessing performance year (PY) 2023 financial performance of Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs); establishing benchmarks for ACOs starting agreement periods in 2024, 2025, and 2026; and calculating factors used in the application cycle for ACOs applying to enter a new agreement period beginning on January 1, 2025, and the change request cycle for ACOs continuing their participation in the program for PY 2025, as a result of significant, anomalous, and highly suspect billing activity for selected intermittent urinary catheters on Medicare Durable Medical Equipment, Prosthetics, Orthotics & Supplies (DMEPOS) claims. Under MSSP, providers of services and suppliers that participate in ACOs continue to receive traditional Medicare fee-for-service (FFS) payments under Medicare Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs participating in two-sided models may also share in losses.
- On September 26, 2025, CMS released a notice entitled, Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year (CY) 2025. This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2025. The CY 2025 AIC threshold amounts are $190 for ALJ hearings and $1,900 for judicial review.
- On September 27, 2024, the Department of Health and Human Services (HHS) released an interim final rule entitled, Health and Human Services Adoption of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. HHS is adopting with this interim final rule the Office of Management and Budget’s (OMB’s) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, to include 12 existing HHS-specific modifications. This interim final rule also repeals HHS’ existing regulations governing the administration of HHS financial assistance awards. The existing HHS-specific modifications are described in the final rule’s preamble. Additionally, the interim final rule corrects citations throughout all relevant HHS regulations.
- On September 27, 2024, CDC released a notice entitled, Disease, Disability, and Injury Prevention and Control Special Emphasis Panel; Notice of Charter Renewal. CDC is announcing the renewal of the charter of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP).
- On September 27, 2024, CMS released a notice entitled, Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024—Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE); Correcting Amendment. This notice corrects technical and typographical errors in the final rule that appeared in the April 23, 2024 Federal Register titled Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024—Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE). The effective date of the final rule was June 3, 2024.
- On September 27, 2024, FDA released a guidance entitled, Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Guidance for Industry and Food and Drug Administration Staff; Availability. This guidance provides clarification to industry and FDA staff of the federal regulations that relate to diagnostic x-ray equipment. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of an “electronic product” as defined in FDA regulations. This guidance supersedes FDA’s 1989 guidance entitled Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment.
- On September 27, 2024, FDA released a notice entitled, Safety and Performance Based Pathway Device-Specific Guidances; Guidance for Industry and Food and Drug Administration Staff; Availability. The device-specific guidances identified in this notice were developed in accordance with the finalized guidance entitled Safety and Performance Based Pathway.
- On September 27, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Recharter for the Council on Graduate Medical Education. In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the Council on Graduate Medical Education (COGME or Council) is rechartered.
Event Notices
October 7, 2024: FDA announced a meeting of the Science Board to the FDA. This is a virtual meeting open to the public.
October 8, 2024: The National Institutes of Health (NIH) announced a meeting of the NIH Office of the Director. This is a virtual meeting open to the public.
October 10, 2024: FDA announced a meeting of the Cardiovascular and Renal Drugs Advisory Committee. This is a hybrid meeting open to the public.
October 16-17: HRSA announced a meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). This is a hybrid meeting open to the public.
October 16-17, 2024: CDC announced a meeting of the Community Preventive Services Task Force. This is a virtual meeting open to the public.
October 21-22, 2024: HHS announced a meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis, and Sexually Transmitted Disease (STD) Prevention and Treatment. This is a hybrid meeting open to the public.
October 22, 2024: CDC announced a meeting of the Advisory Committee to the Director (ACD). This is a hybrid meeting open to the public.
November 6, 2024: CDC announced a meeting of the Clinical Laboratory Improvement Advisory Committee. This is a virtual meeting open to the public.
November 7, 2024: CDC announced a meeting of the Mine Safety and Health Research Advisory Committee. This is a hybrid meeting open to the public.
October 22-23, 2024: HRSA announced a meeting of the National Advisory Council on Migrant Health. This is a hybrid meeting open to the public.
October 30, 2024: FDA announced a meeting of the Patient Engagement Advisory Committee. This is a virtual meeting open to the public.
November 15, 2024: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a virtual meeting open to the public.
II. Hearings & Markups
- On September 24, 2024, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy. The sole witness was Lars Fruergaard Jørgensen, President and Chief Executive Officer (CEO), Novo Nordisk.
- On September 24, 2024, the Senate Finance Committee held a hearing entitled, Chaos and Control: How Trump Criminalized Women’s Health Care. Witnesses included Kaitlyn Joshua; Amelia Huntsberger, MD; Christina Francis, MD, CEO, American Association of Pro-Life Obstetricians and Gynecologists; Heather Jacker, JD, Hacker Stephens LLP; and, Michele Goodwin, JD, Linda D. & Timothy J. O'Neill Professor of Constitutional Law and Global Health Policy, Georgetown University School of Law.
III. Reports, Studies, & Analyses
- On September 24, 2024, the Office of the Inspector General (OIG) released a report entitled, Additional Oversight of Remote Patient Monitoring in Medicare Is Needed. OIG conducted a review highlighting the need for greater oversight of remote patient monitoring (RPM) in Medicare, given its expanding use. Between 2019 and 2022, the use of RPM services increased significantly, but about 43 percent of enrollees did not receive all three components of monitoring, raising concerns about its appropriate use. Additionally, OIG and CMS identified potential fraud risks and gaps in Medicare’s oversight, such as missing information about who ordered the monitoring. To address these issues, OIG recommended several steps for CMS, including implementing safeguards to ensure proper use and billing, requiring documentation of the ordering provider, developing methods to track what health data are being monitored, providing education to providers on RPM billing, and monitoring companies that bill for RPM. CMS agreed with or took into consideration all of the recommendations.
- On September 23, 2024, OIG released a report entitled, Medicare and Medicaid Enrollees in Many High-Need Areas May Lack Access to Medications for Opioid Use Disorder. The report found that many Medicare and Medicaid enrollees in high-need areas lack access to medications for opioid use disorder (MOUD), despite the growing opioid crisis. In 2022, hundreds of counties in need of these services had no office-based buprenorphine providers or opioid treatment programs. Even in areas with MOUD providers, many did not treat Medicare or Medicaid patients, often due to factors like Medicare Advantage (MA) prior authorization requirements, low Medicaid reimbursement rates, and a lack of public information on provider locations. In the report, OIG recommended that CMS focus efforts on increasing the number of MOUD providers in high-need counties, both for Medicare and Medicaid enrollees, and assess whether Medicaid reimbursement rates are sufficient to attract and retain providers. Additionally, OIG urged CMS to collaborate with the Substance Abuse and Mental Health Services Administration (SAMHSA) to create a list of active buprenorphine providers. While CMS supported the spirit of the recommendations, it did not explicitly concur, citing broader HHS initiatives to improve access to MOUD services.
IV. Other Health Policy News
- On September 25, 2024, the House of Representatives passed a continuing resolution (CR), H.R. 9747, to maintain federal funding through December 20, 2024, which the Senate passed within hours. None of the 12 fiscal year (FY) 2025 appropriations bills have been enacted this year, requiring a short-term spending bill to avoid a government shutdown on October 1, 2024. The CR includes several expiring health provisions including a reporting delay of the Medicare clinical laboratory test payment reductions and reporting requirements, funding for ongoing implementation of the No Surprises Act, and an extension of FDA’s pediatric priority review voucher (PRV) program. Additionally, the CR allows the Federal Emergency Management Agency (FEMA) to access its full-year FY 2025 appropriations, a significant concern as late season storms head into the U.S. mainland. The House passed the CR by a vote of 341-82, and the Senate advanced the CR by a vote of 78-18. Both bodies have now departed Washington, DC and are set to return on November 12, 2024 following the elections, setting up deliberations on an expected sizable omnibus spending bill. The text of the CR is available here.
- On September 26, 2024, the Biden Administration released new guidance on Medicaid and Children’s Health Insurance Program (CHIP) coverage for children. This comprehensive guidance, the most detailed Medicaid Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) framework released in a decade, highlights best practices and strategies for states to meet Medicaid’s EPSDT requirements. The guidance reinforces EPSDT guidelines and requirements, ensuring that children receive a comprehensive range of medically necessary services, including well-child visits, mental health care, and services like dental and vision care. The guidance outlines strategies for states to improve care coordination, expand behavioral health services, address the needs of children with disabilities, and enhance the workforce. It also emphasizes the importance of early intervention and preventive care to avert health problems. Additionally, the guidance highlights efforts to address the youth mental health crisis, urging states to develop benefit packages for behavioral health services, especially in primary care settings. The guidance also aligns with the HHS Roadmap to Behavioral Health Integration and the Administration’s Unity Agenda, focusing on integrated, culturally competent care to achieve health equity and support overall child development. A press release with more information is available here.
- On September 26, 2024, the Biden Administration announced over $1.5 billion in grants for FY 2024 through SAMHSA to support State and Tribal Opioid Response programs. This funding is part of the Administration’s Unity Agenda and the HHS Overdose Prevention Strategy, aiming to address the opioid crisis through evidence-based practices in prevention, harm reduction, treatment, and recovery support. The FY 2024 grants emphasize expanding access to medications for opioid use disorder (OUD), particularly for youth and young adults, and enhancing services within correctional facilities. Notably, funding for Tribal Opioid Response programs has increased by over 14.5 percent from the previous year, with targeted support for tribes experiencing high overdose rates. Since their inception in 2018, these grants have significantly improved treatment access and recovery support, leading to enhanced housing stability and better mental health outcomes for participants. A press release with more information is available here.
- On September 24, 2024, the Biden Administration announced a $75 million investment to improve rural health care, focusing on three key areas: substance use disorder (SUD), maternal health, and hospital sustainability. $54 million has been allocated to expand opioid and behavioral health services in rural communities, with the goal of enhancing access to treatment and recovery resources. An additional $9 million will strengthen maternal health services in the Southern Delta region to support pregnant women throughout their care journey. Furthermore, nearly $12 million will aid rural hospitals in expanding essential services, enhancing financial stability, and keeping care local to improve patient outcomes. A press release with more information is available here.
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